EUCTR2024-000122-18-Outside-EU/EEA进行中（未招募）1 期
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, DoseEscalation Study to Evaluate the Safety, Reactogenicity, andImmunogenicity of mRNA-1345, an mRNA Vaccine TargetingRespiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years,Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged= 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Healthy young adults =18 to =49 years of age, women of child-bearing potential =18 to =40 years of age, healthy older adults =65 to <80 years of age, Japanese older adults = 60 years of age, and children =12 to < 60 months of age.
- •- Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- •- Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.
- •Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):
- •- Has a body mass index from =18 kilograms (kg)/meter (m)^2 to =35 kg/m^2.
- •- Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14.
- •- Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding.
- •Specific inclusion criteria for children 12 to 59 months of age:
- •- Seropositive for RSV-neutralizing Abs at Screening.
- •- Has received routine immunizations appropriate for age per local guidance.
- •- Current height and weight above the third percentile for age.
- •Specific inclusion criteria for Japanese older adults:
- •- Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 46
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 288
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 317
排除标准
- •- Has Screening laboratory values Grade =1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
- •- Is acutely ill or febrile on the day of the first injection.
- •- Has a significant medical history, including but not limited to:
- •- Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
- •- Chronic hepatitis or suspected active hepatitis.
- •- Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
- •- Dermatologic conditions that could affect local solicited adverse reaction (AR) assessments.
- •- Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention.
- •- Autoimmune disease except for Hashimoto's disease.
- •- Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed.
- •- Intravenous blood products (red cells, platelets, and immunoglobulins [Ig]) within 3 months prior to enrollment.
- •- Has received or plans to receive any licensed or authorized vaccine, to include Coronavirus Disease 2019 (COVID-19) vaccines, = 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Non-study vaccinations should not be delayed.
- •- Has a history of myocarditis, pericarditis, or myopericarditis.
- •Specific exclusion criteria for older adults (Cohorts 7-11 and 15):
- •- Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure >160 millimeters of mercury (mmHg) at the Screening visit.
- •- Known history of hypotension or systolic blood pressure <85 mmHg at the Screening visit.
- •- Poorly controlled diabetes mellitus (per determination of the Investigator).
- •- Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma).
- •- Significant chronic cardiovascular disease (per determination of the Investigator).
- •- Resides in a nursing home.
- •- Anticipates the need for immunosuppressive treatment at any time during participation in the study.
- •- Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ).
- •Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6):
- •- Has received any monoclonal antibody at any time prior to the Screening visit.
- •- Prior hospitalization for RSV disease in the last 2 years.
- •- Receipt of any prior systemic immunosuppressants or immune-modifying drugs.
- •- Any history of febrile seizures (inclusive of single simple febrile seizure).
- •- History of epilepsy.
- •- History of meningitis.
研究者
相似试验
进行中（未招募）
1 期
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 MonthsAcute lower respiratory infectionCTIS2022-502022-41-00Moderna Inc.458
进行中（未招募）
1 期
A study on the reactogenicity, safety and immune response of a targeted immunotherapy against HSV in healthy Japanese participants aged 18-40 yearsgenital herpesJPRN-jRCT2031230226Ogawa Masayuki50
进行中（未招募）
1 期
BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with ZolgensmaSpinal muscular atrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2022-000956-12-PLBiogen Idec Research Limited62
尚未招募
不适用
A Randomized, Blinded, Placebo-Controlled, Phase 1 Single Ascending Dose Study in Healthy Adult Male Volunteers and an Open-Label Multiple Ascending Dose Study in Pediatric SMA Participants Previously Treated with Onasemnogene Abeparvovec (Zolgensma*) to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB115SMASpinal muscular atrophy10029317NL-OMON53796Biogen Idec Research Limited42
招募中
1 期
BIIB115 in Healthy Volunteers and Pediatric SMA Patients Previously Treated with ZolgensmaSpinal muscular atrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2022-000956-12-DEBiogen Idec Research Limited24